Lupin Pharmaceuticals Inc., (Lupin) announced that the US Food and Drug Administration has approved the company’s supplemental New Drug Application (sNDA) to expand the use of Solosec (secnidazole) in the treatment of bacterial vaginosis (BV) for female patients 12 years of age and older and in the treatment of trichomoniasis for all patients 12 years of age and older.
BALTIMORE, Jan. 27, 2022 /PRNewswire/ -- Lupin Pharmaceuticals Inc., (Lupin), and Exeltis USA Inc. announced a promotional agreement for Exeltis to promote SOLOSEC® along with Exeltis' existing line of Women's Health products, further enhancing value to OBGYNs and their patients. SOLOSEC® is indicated for the treatment of Bacterial Vaginosis in adult women (a common vaginal infection) and Trichomoniasis in adults (the most common non-viral, curable sexually transmitted infection in the U.S.).
SOLOSEC demonstrated a 92.2 per cent clinically and statistically significant cure rate for patients with trichomoniasis based on…
Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of global pharma major Lupin Limited (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) to expand the use of SOLOSEC® (secnidazole) to include the treatment of trichomoniasis in adults. Trichomoniasis vaginalis is the most common non-viral, curable sexually transmitted infection (STI) in the U.S., affecting an estimated three to five million people every year.[1] SOLOSEC® was approved in the U.S. in 2017 for the treatment of bacterial vaginosis (BV) in adult women. The supplemental approval makes SOLOSEC® the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV.
MUMBAI, India and BALTIMORE, Feb. 1, 2021 /PRNewswire/ -- Lupin Pharmaceuticals Inc. (Lupin), global pharmaceutical company, announced today a partnership with Phil, Inc., which helps deliver cost-effective next-generation access solutions for patients who are prescribed Solosec® (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women.
MUMBAI, India and BALTIMORE, Nov. 16, 2020 /PRNewswire/ -- Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of Lupin Limited (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has accepted their supplemental New Drug Application (sNDA) for Solosec® (secnidazole) for the treatment of trichomoniasis in adults and adolescents. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of June 30, 2021. Trichomoniasis vaginalis is the most common non-viral, curable sexually transmitted infection (STI) in the U.S., affecting an estimated 3 to 5 million people.1 Solosec® 2 g oral granules is currently FDA-approved to treat bacterial vaginosis (BV) in adult women.
BALTIMORE, Aug. 14, 2020 /PRNewswire/ -- Lupin Pharmaceuticals Inc. (Lupin) announced today results from its pivotal Phase 3 clinical trial to assess efficacy and safety of single-dose Solosec® (secnidazole) 2g oral granules in female patients with trichomoniasis, the most common non-viral, curable sexually transmitted infection (STI) in the U.S. The trial results showed a clinically and statistically significant response rate, or microbiological cure, in patients treated with Solosec® as compared to placebo (p<0.001). The data were presented at the 2020 Infectious Diseases Society for Obstetrics & Gynecology (IDSOG) Virtual Annual Meeting.
Lupin Pharmaceuticals Inc., the U.S. based wholly-owned subsidiary of Lupin Limited (Lupin), and Ceek Women's Health (Ceek), a leading pioneer in modern gynecological care, today announced an agreement to add Ceek's line of women's health products to Lupin's promotional offering in the United States, further enhancing the value that Lupin provides to OB/GYNs and their patients. The promotional arrangement includes detailing and demonstration of Ceek's products, alongside Lupin's women's health flagship product, Solosec® (secnidazole) 2g oral granules, indicated for the treatment of bacterial vaginosis (BV), a common vaginal infection in adult women. Solosec® is a 5-nitroimidazole antimicrobial agent.
Lupin Pharmaceuticals Inc. (Lupin), the U.S. based wholly owned subsidiary of Lupin Limited, announced today that Solosec® (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women has received preferred coverage effective immediately on the Express Scripts National Preferred, Flex, and Basic commercial formularies. As a preferred medication, Solosec® will be available at a lower out-of-pocket cost to the represented Express Scripts plan members compared to BV medications which are non-preferred or excluded.
NEWARK, N.J., March 23, 2017 /PRNewswire/ -- Symbiomix today announced that the US Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for its lead investigational product candidate Solosec™ (secnidazole oral granules), an innovative antibiotic designed to treat bacterial vaginosis (BV). In accordance with the FDA's priority 6-month review designation, the agency has established a user-fee goal date under the Prescription Drug User Fee Act (PDUFA) of September 17, 2017. Symbiomix submitted the NDA filing in January 2017.